Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-05-23 @ 12:08 PM
Study NCT ID:
NCT03732651
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2018-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Non-pulsatile Blood Flow on CO2-Reactivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each patient served as his own control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2013-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-04', 'studyFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2018-11-04', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CO2- Reactivity of cerebral vessels during cardiopulmonary bypass using nonpulsatile blood flow and postoperative on ICU under physiological pulsatile blood flow', 'timeFrame': 'first time-point: intraoperative, during cardiopulmonary bypass, duration up to 300minutes. Second time-point: on ICU, postoperatively under pulsatile blood flow, duration of measurement up to 100minutes for each patient', 'description': 'Relation between PaCO2 level and cerebral blood flow velocity will be assessed during non-pulsatile and pulsatile blood flow. Measurements will be performed using trancranial doppler to measure flow velocity of the middle cerebral artery. Further, NIRS will be used to measure oxygen saturation of the brain. Measurements will be performed during step changes of PaCO2 (at 30mmHg, 40mmHg and 50mmHg.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebrovascular Circulation']}, 'referencesModule': {'references': [{'pmid': '31888721', 'type': 'DERIVED', 'citation': 'Veraar CM, Rinosl H, Kuhn K, Skhirtladze-Dworschak K, Felli A, Mouhieddine M, Menger J, Pataraia E, Ankersmit HJ, Dworschak M. Non-pulsatile blood flow is associated with enhanced cerebrovascular carbon dioxide reactivity and an attenuated relationship between cerebral blood flow and regional brain oxygenation. Crit Care. 2019 Dec 30;23(1):426. doi: 10.1186/s13054-019-2671-7.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothezised that CO2-reactivity of cerebral vessels is affected by systemic non-pulsatile blood flow. Patients undergoing elective cardiac surgery with CPB were enrolled in this prospective case control study. Blood flow velocity in the middle cerebral artery as well as regional cerebral oxygenation was determined during step changes of PaCO2 between 30, 40, and 50 mmHg. Measurements were conducted intraoperatively during non-pulsatile as well as postoperatively after admission to the ICU under pulsatile blood flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing elective cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Carotid artery stenosis (\\> 50%)\n* Neurological pathologies\n* COPD with CO2 retention\n* Women of childbearing age'}, 'identificationModule': {'nctId': 'NCT03732651', 'briefTitle': 'The Impact of Non-pulsatile Blood Flow on CO2-Reactivity', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'The Impact of Non-pulsatile Perfusion on Cerebral Blood Flow and Brain Oxygenation', 'orgStudyIdInfo': {'id': '1018730'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'non-pulsatile blood flow', 'interventionNames': ['Procedure: alteration of PaCO2 level']}, {'type': 'EXPERIMENTAL', 'label': 'pulsatile blood flow', 'interventionNames': ['Procedure: alteration of PaCO2 level']}], 'interventions': [{'name': 'alteration of PaCO2 level', 'type': 'PROCEDURE', 'description': 'step changes between 30, 40 and 50 mmHg', 'armGroupLabels': ['non-pulsatile blood flow', 'pulsatile blood flow']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cecilia Veraar', 'investigatorFullName': 'Cecilia Veraar', 'investigatorAffiliation': 'Medical University of Vienna'}}}}